Therapy management techniques for an implantable medical device

ABSTRACT

Disclosed is a method and apparatus for automatically adjusting drug infusion rate to optimize treatment therapy. The implantable medical device communicates with a database or algorithm controlled by a caregiver or physician. Thus, the caregiver may request a therapy change (e.g., infusion rate versus time, pump clock settings, etc.) or a therapy management module may automatically activate the therapy change at some future time for convenience, or for technical or clinical reasons.

[0001] This application claims priority to provisional U.S. ProvisionalApplication Ser. No. 60/259,116, filed Dec. 29, 2000, which isincorporated herein by reference in its entirety.

[0002] This patent application is related to the following co-pendingpatent applications, each of which having the same named inventor andfiling date as the present application:

[0003] a. U.S. patent application Ser. No. ______, entitled“Non-Conformance Monitoring And Control Techniques For An ImplantableMedical Device,” having attorney reference no. 011738.00045 (based onU.S. Provisional Application Ser. No. 60/259,008, filed Dec. 29, 2000);

[0004] b. U.S. patent application Ser. No. ______, entitled “DrugManagement Techniques For An Implantable Medical Device,” havingattorney reference no. 011738.00044 (based on U.S. ProvisionalApplication Ser. No. 60/259,115, filed Dec. 29, 2000); and

[0005] c. U.S. patent application Ser. No. ______, entitled “PatientScheduling Techniques For An Implantable Medical Device,” havingattorney reference no. 011738.00046 (based on U.S. ProvisionalApplication Ser. No. 60/259,022, filed Dec. 29, 2000).

[0006] Each of these related co-pending patent applications areincorporated herein by reference in their entireties.

FIELD OF THE INVENTION

[0007] This invention relates to implantable therapy delivery devicessuch as implantable drug delivery devices, and more particularly relatesto automated therapy management systems and methods for implantabletherapy delivery devices.

BACKGROUND OF THE INVENTION

[0008] The medical device industry produces a wide variety of electronicand mechanical devices suitable for use outside and inside the body fortreating patient disease conditions. Devices used outside the body aretermed external while devices used inside the body are termedimplantable and include therapeutic substance infusion devices such asimplantable drug pumps. Clinicians use medical devices alone or incombination with therapeutic substance therapies and surgery to treatpatient medical conditions. For some medical conditions, medical devicesprovide the best, and sometimes the only, therapy to restore anindividual to a more healthful condition and a fuller life. Implantabletherapeutic substance infusion devices can be used to treat conditionssuch as pain, spasticity, cancer, and a wide variety of other medicalconditions.

[0009] Implantable medical devices have important advantages over otherforms of therapeutic substance administration. For example, oraladministration is often not workable because the systemic dose of thesubstance needed to achieve the therapeutic dose at the target sight maybe too large for the patient to tolerate without very adverse sideeffects. Also, some substances simply will not be absorbed in the gutadequately for a therapeutic dose to reach the target sight. Moreover,substances that are not lipid soluble may not cross the blood-brainbarrier adequately if needed in the brain. In addition, infusion ofsubstances from outside the body requires a transcutaneous catheter,which results in other risks such as infection or catheter dislodgement.Further, implantable medical devices avoid the problem of patientnoncompliance, namely the patient failing to take the prescribed drug ortherapy as instructed.

[0010] Implantable medical devices are often used in conjunction withvarious computer and telecommunication systems and components.Information obtained by the implantable medical device may be stored andsubsequently transmitted to a physician or patient caregiver or adatabase on demand or automatically. Many ways of using the informationare known including decision making to provide optimum medical care tothe person with the medical condition.

[0011] An implantable therapeutic substance infusion device such as animplantable drug delivery device is implanted by a clinician into apatient at a location appropriate for the therapy that interferes aslittle as practicable with normal patient activity. This location istypically a subcutaneous region in the lower abdomen. The proximal ornear end of the infusion catheter is connected to the drug pump infusionoutlet. The catheter is simply a flexible tube with a lumen typicallyrunning the length of the catheter. The distal or far end of thecatheter is positioned to infuse a drug or drug combination to a targetsite in the patient. Target sights in the body included but are notlimited to an internal cavity, any blood vessel, any organ, or othertissue in the body. The drug or other therapeutic substance flows fromthe pump via the lumen in the catheter at a programmed infusion rate totreat the disease condition. The pump typically includes an expansiblereservoir for containing a refillable supply of drug. For example, U.S.Pat. No. 4,692,147 (Duggan) and No. 5,445,616 (Kratoska et al) disclosetypes of implantable pumps that can be used.

[0012] Examples of diseases that are treatable include spasticity andchronic intractable pain. To treat spasticity, the distal tip of thecatheter is typically surgically positioned in the intrathecal space ofthe patient's spinal column. Drug flows out of the distal tip into thecerebral spinal fluid where it baths the spinal cord. By virtue ofmolecular action on nervous tissue in the spinal cord, the patient'sspasticity symptoms are dramatically reduced and the patient becomesmuch more comfortable and competent. Pain patients are treated in muchthe same way.

[0013] The infusion rate of the drug pump is typically programmed to bevariable over time. The rate is usually controlled by certain componentsin the pump. The controlled infusion rate is often further set by usingan external device or programmer to transmit into the pump, instructionsfor the controlled infusion. The controlled infusion may be variable astime passes according to the needs of the patient. The instructionsprovided to the pump to control the infusion rate of the drug pump aretypically determined by a medical person. In some cases the patient isable to provide the instructions to the pump via an externalpatient-programming device. In contrast, fixed rate pumps usually cannotbe programmed and are only capable of constant infusion rate.

[0014] Once implanted, the implantable medical device will requirere-programming to account for changes in the desire therapy, changes inthe condition being treated, or changes in the placement of the leaddelivering the therapy to the body. This can be accomplished in anynumber of ways including, for example, the patient may manually adjustthe treatment therapy, or the treating physician may manually adjust orre-program the implanted device. In either of these cases, there is nomechanism by which the implanted device may automatically make therapyadjustments or store prior therapy changes for later use and analysis.

[0015] It is therefore desirable to provide an implantable therapydelivery system that is capable of automatically making therapyadjustments. It is also desirable to provide an implantable therapydelivery system that provides historical information relating to thetherapy changes made to the implanted devices.

BRIEF SUMMARY OF THE INVENTION

[0016] In accordance with a preferred embodiment of the presentinvention, the drug infusion rate is automatically adjusted bycommunicating with an outside-the-pump database or algorithm, the lattercontrolled by a caregiver or physician or through use of an expertsystem database. Thus, the caregiver may request a therapy change (e.g.,infusion rate versus time, pump clock settings, etc.) for a patient inreal time while a Drug Pump Management Controller System (DPMCS) or atherapy management module may automatically activate the therapy changeat some future time for convenience, or for technical or clinicalreasons. Technical reasons may include, for example, where routineaccessibility to the patient is difficult. The therapy management modulemay have direct control to reprogram the pump and/or may providerecommendations to the caregiver/physician.

[0017] Alternatively, the pump may automatically detect (or with theaddition of patient message to the pump) that the therapy is not givingacceptable results, and the pump/system would automatically inform thecaregiver/physician of this status.

[0018] The pump preferably is coupled to one or more sensors to sensephysiologic or other characteristics of the patient to automaticallyprovide closed-loop feedback control. The automated data acquisition(e.g., therapy parameters, physiologic parameters, etc.) would bepossible by storing any changes to the therapy in a database.

[0019] The objects, advantages novel features, and the further scope ofapplicability of the present invention will be set forth in the detaileddescription to follow, taken in conjunction with the accompanyingdrawings, and in part will become apparent to those skilled in the artupon examination of the following, or may be learned by practice of theinvention. The objects and advantages of the invention may be realizedand attained by means of the instrumentalities and combinationsparticularly pointed out in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] These and other advantages and features of the invention willbecome apparent upon reading the following detailed description andreferring to the accompanying drawings in which like numbers refer tolike parts throughout and in which:

[0021]FIG. 1 is a schematic block diagram of an overall system fortherapy management of an implantable therapy delivery device inaccordance with a preferred embodiment of the present invention.

[0022]FIG. 2 is a diagrammatic view of a drug delivery device for usewith the present invention as implanted within a patient.

[0023]FIG. 3 illustrates a typical position in a patient of animplantable drug delivery device with a catheter implanted at or near aspinal cord.

[0024]FIG. 4 illustrates another typical position in a patient of animplantable drug delivery device with a catheter implanted at or near abrain.

[0025]FIG. 5 depicts the implantable drug delivery device.

[0026]FIG. 6 shows an implantable pump communicating via telemetry withan external handheld programming device.

[0027]FIG. 7 is a diagrammatic view of an exemplary implantable drugdelivery device for use with the present invention depicting the variouslayered components of the device.

[0028]FIG. 8 shows a block diagram of an implantable drug deliverydevice embodiment for use with the present invention.

[0029]FIG. 9 is a schematic block diagram of the electronic modules ofthe implantable drug pump in accordance with a preferred embodiment ofthe present invention.

[0030]FIG. 10 is a schematic block diagram of the therapy managementmodule of the implantable drug pump in accordance with a preferredembodiment of the present invention.

[0031]FIG. 11 is a flow chart depicting the process for determiningwhether therapy in the implantable device to be refilled in accordancewith a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0032] In accordance with the present invention, an implantable therapydelivery device is equipped with automated management controlcapabilities. Although not required, the invention will be described inpart in the general context of computer-executable instructions, such asprogram modules. Generally, program modules include routines, programs,objects, scripts, components, data structures, etc. that performparticular tasks or implement particular abstract data types. Programmodules may be part of a single software program or may be implementedas separate software programs.

[0033]FIG. 1 is a schematic block diagram of an overall system fortherapy management of an implantable therapy delivery device inaccordance with a preferred embodiment of the present invention. Theoverall system generally includes an implantable therapy delivery device105 implantable within a patient, an external device or programmer 110having a therapy management module 115 in accordance with a preferredembodiment of the present invention, a database 120, and a computingnetwork 135 such as the Internet coupled to various entities involved inthe healthcare management of the patient. Such entities may include, forexample, an insurance provider 125, a pharmacy 140, a hospital 145, acaregiver 150, a physician 155, and/or a device manufacture 130. Inalternative embodiments, the therapy management module 115 may beimplemented in other parts of the overall system for therapy managementincluding, for example, in the implantable therapy delivery device 105,or on a server accessible over the computing network 135. Furtherdetails of the therapy management module are discussed in further detailherein. The implantable therapy delivery device 105 may be animplantable drug pump or an implantable pulse generator or both. Theimplantable therapy delivery device 105 is coupled to be inbi-directional communication with the external device 110 via telemetry.The external device 110 may be any computing device capable ofcommunicating with the implantable therapy delivery device 105,including for example, a physician programmer, a patient programmer, ascreening device, a data acquisition device, and the like. Thebi-directional communications may be of any type of telemetry includingRF.

[0034] The external device 110 is preferably coupled to the computingnetwork 135 for communicating with various healthcare entities essentialto the management of the treatment therapy of the patient. Also coupledto the network 135 and in communication with the external device 110 isthe database 120 storing therapy management information relating to thepatient. The computing network 135 may be, for example, a public networksuch as the Internet, an intranet, an extranet, or a private network.The computing network 135 enables the external device 110 to communicatewith the various healthcare entities and the database 120.

[0035] The external device 110 may be coupled to the computing network135 either directly through a modem or may be networked to a personalcomputer that is coupled to the computing network 135 through knowntechniques. The various other entities 125,130,140-155 are preferablycoupled to the computing network 135 via a general-purpose computingdevice. The computing devices used by these entities preferably haveinstalled therein a software application that communicates with the drugmanagement module to perform the various scheduling functions to beperformed.

[0036] As discussed, implantable drug delivery devices are generallyknown in the art. U.S. Pat. No. 4,692,147 (Duggan) and No. 5,445,616(Kratoska et al), for example, illustrate the general features of thesedevices. FIG. 2 is a diagrammatic illustration of an exemplaryimplantable drug delivery device 105 for use with the present invention.The system includes the device 105 that may be implanted below the skinof a patient 10 in the abdomen or any other location of the body. Thedevice 105 is typically a pump that delivers drug to a catheter 16/18that is positioned to deliver the drug to specific infusion sites withinthe patient's body (in this case, the spinal cord 12). The distal end ofthe catheter 16/18 terminates in a cylindrical hollow tube having adistal end implanted into a portion of the body by conventional surgicaltechniques. The catheter 16/18 is joined to the implanted device 105 inthe manner shown, and may be secured to the device 105 by, for example,screwing the catheter 16/18 onto a catheter port of the device 105.

[0037] The implantable system 105 may include one or more sensors toprovide closed-loop feedback control of the drug delivery system toprovide enhanced results. Sensors can be used with a closed loopfeedback system to automatically determine the level of treatmenttherapy necessary to alleviate the symptoms of the disorder beingtreated. The sensor is attached to or implanted into a portion of apatient's body suitable for detecting symptoms of the disorder beingtreated, such as a motor response or motor behavior. The sensor isadapted to sense an attribute of the symptom to be controlled or animportant related symptom. For movement disorders that result inabnormal movement of an arm of the patient, such as an arm, the sensormay be a motion detector implanted in the arm. For example, the sensormay sense three-dimensional or two-dimensional motion (linear rotationalor joint motion), such as by an accelerometer. One such sensor suitablefor use with the present invention is described in U.S. Pat. No.5,293,879 (Vonk). The sensor also may be placed in the implantable drugdelivery device, for example, to sense drug levels. Those skilled in theart will appreciate that any type of sensor may be utilized with thepresent invention. The output of the sensor may be coupled by a cable orvia telemetry to the input of an analog to digital converter within theimplantable drug delivery device. Alternatively, the output of anexternal sensor would communicate with the implantable drug deliverydevice through a telemetry downlink.

[0038] The implantable drug delivery device 105 can be used for a widevariety of therapies to treat medical conditions (also known as medicalindications) such as pain, spasticity, cancer, and many other medicalconditions. The implantable drug delivery device 105 is typicallyimplanted by a clinician, such as a surgeon, using a sterile surgicalprocedure performed under local, regional, or general anesthesia. Beforeimplanting the therapeutic substance infusion device, a catheter istypically implanted with the distal end position at the desiredtherapeutic substance infusion site and the proximal end tunneled to thelocation where the therapeutic substance infusion device is to beimplanted. The implantable therapeutic substance infusion device isgenerally implanted subcutaneously about 2.5 cm (1.0 inch) beneath theskin where there is sufficient subcutaneous tissue to support theimplanted system. As one example, FIG. 3 illustrates the implantabledrug delivery device 105 coupled to catheter 205, both of which areunder the surface of the skin 4. The catheter 205 is positioned with itsdistal tip in the intrathecal space of the spinal column 3. As anotherexample, FIG. 4 shows the implantable drug delivery device 105 forinfusion of drug into to brain B. The device 105 is coupled to catheter205 with a distal end terminating within the brain B. FIG. 5 illustratesthe various components of the implantable drug delivery device 105 thatare implanted within the patient 10.

[0039] Once the therapeutic substance infusion device is subcutaneouslyimplanted into the patient, the incision can be sutured closed and thetherapeutic substance infusion device can begin operation. Theimplantable drug delivery device 105 operates to infuse a therapeuticsubstance at a programmed rate into a patient. The therapeutic substanceis a product or substance intended to have a therapeutic effect such aspharmaceutical compositions, genetic materials, biologics, and othersubstances. Pharmaceutical compositions are chemical formulationsintended to have a therapeutic effect such as intrathecal antispasmodics(e.g., balcofen), pain medications, chemotherapeutic agents, and thelike. Pharmaceutical compositions are often configured to function in animplanted environment with characteristics such as stability at bodytemperature to retain therapeutic qualities, concentration to reduce thefrequency of replenishment, and the like. Genetic materials aresubstances intended to have a direct or indirect genetic therapeuticeffect such as genetic vectors, genetic regulator elements, geneticstructural elements, DNA, and the like. Biologics are substances thatare living matter or derived from living matter intended to have atherapeutic effect such as stem cells, platelets, hormones, biologicallyproduced chemicals, and the like. Other substances are substancesintended to have a therapeutic effect yet are not easily classified suchas saline solution, fluoroscopy agents, and the like. As used herein,the term drug shall refer generally to any therapeutic substance.

[0040] The therapeutic substance can be replenished in some embodimentsof the implanted therapeutic substance infusion device by inserting anon-coring needle connected to a syringe filled with therapeuticsubstance through the patient's skin into a septum and into a reservoirin the therapeutic substance infusion device to fill the implanteddevice reservoir. Refill kits are available which include the drug andall other necessary equipment needed for the medical attendant to refillthe pump.

[0041] A therapeutic substance bolus can be administered by a clinician,in some embodiments, by inserting a non-coring needle connected to asyringe into a catheter access port. This procedure can be used forseveral other reasons including reopening the catheter if it becomesoccluded or to withdraw a sample of cerebral spinal fluid forinvestigative purposes.

[0042]FIG. 6 illustrates a typical pump programming technique. Anexternal device, a handheld programming device 110 in this embodiment,transmits and receives radio frequency signals 212 to and from theimplantable drug delivery device 105. The radio frequency signals 212sent to the pump, often called the downlink signal, contain theprogramming instructions needed by the implantable drug delivery device105 for it to correctly infuse a drug into the patient from its drugreservoir. Many other types of information may be sent to the pumpincluding requests for information residing in the pump in accordancewith the present invention (discussed herein).

[0043] The implantable drug delivery device 105 may continuously orperiodically store various types of information including, for examplewithout limitation, pump diagnostics, drug delivery information, batterlife, etc. Further, the implantable drug delivery device 105 may receiveinformation from various sensors inside the pump or information fromsensors integral with the catheter, thereby obtaining physiologicalinformation about the patient. Even further, the implantable drugdelivery device 105 may store historical data about the drug infusingprofile, patient requests for more drug or other such information.

[0044] Such information stored in the pump may be valuable to thetreating physician and/or the medical device supplier and can beretrieved from the pump. In particular, the information stored in theimplantable drug delivery device 105 may be retrieved in response to arequest by the pump from the programming device 110. After the requestis received and processed in the implantable drug delivery device 105,the implantable drug delivery device 105 prepares the requestedinformation and sends it to the programming device 110, sometimes calleduplink data. The pump information received by the programming device 110is processed and converted to intelligible data for clinical ortechnical use. This intelligible data can be used for many purposesincluding management of the pump performance, management of the patienttherapy, and/or other medical or record-keeping purposes.

[0045] Referring back to the embodiment of the implantable drug deliverydevice, the present invention may be implemented for use any number ofsuch devices. FIG. 7 show one such example of the implantable drugdelivery device 105 and FIG. 8 shows a block diagram of the implantabledrug delivery device 105. The implantable drug delivery device 105generally comprises a housing 1141, a power source 1242, a therapeuticsubstance reservoir 1244, a therapeutic substance pump 1246, andelectronics 1248. The housing 1141 is manufactured from a material thatis biocompatible and hermetically sealed such as titanium, tantalum,stainless steel, plastic, ceramic, and the like. The power source 1242is carried in the housing 1141. The power source 1242 is selected tooperate the therapeutic substance pump 1246 and electronics 1248 such asa lithium ion (Li+) battery, capacitor, and the like.

[0046] The therapeutic substance reservoir 1244 is carried in thehousing 1141. The therapeutic substance reservoir 1244 is configured forcontaining a therapeutic substance. The therapeutic substance reservoir1244 may be refilled with therapeutic substance while implanted via port1140. The therapeutic substance pump 1246 is carried in the housing1141. The therapeutic substance pump 1246 is fluidly coupled to thetherapeutic substance reservoir 1244 and electrically coupled to thepower source 1242. The therapeutic substance pump 1246 is a pump that issufficient for infusing therapeutic substance such as a piston pump, aperistaltic pump that can be found in the SynchroMed® Infusion Systemavailable from Medtronic, Inc., or a pump powered by a stepper motor, anAC motor, a DC motor, an electrostatic diaphragm, a piezoelectricdiaphragm, a piezoelectric motor, a solenoid, a shape memory alloy, andthe like.

[0047] The electronics 1248 are carried in the housing 1141 and coupledto the therapeutic substance pump 1246 and the power source 1242. Theelectronics 1248 include a processor 1405, memory 1410, an infusionprogram in memory, and transceiver circuitry 1415. The processor 1405can be an Application Specific Integrated Circuit (ASIC) state machine,a gate array, controller, and the like. The electronics 1248 areconfigured to control the infusion rate of the therapeutic substancepump 1246 and can be configured to operate many other features such aspatient alarms 1420 and the like. The infusion program resides in memoryand is capable of being modified once the implantable drug deliverdevice is implanted. The transceiver circuitry 1415 is coupled to theprocessor 1405 for externally receiving and transmitting therapeuticsubstance infusion device information.

[0048] As discussed, the present invention is implemented in part thegeneral context of computer-executable instructions, such as programmodules. In a preferred embodiment as discussed herein, some of thefeatures of the present invention are implemented within a therapymanagement module 115. The implantable device 105 would provide viatelemetry the necessary information for the external device 110 toprovide the therapy management functionality of the present invention.In the embodiment where the therapy management module 115 is within theimplantable device 105, it may be found in the electronic module 32.

[0049] Referring to the schematic block diagram of FIG. 9, theimplantable device 105 includes various electrical and softwarecomponents including a microprocessor 730, a flow control module 740 forcontrolling the flow of drug from the reservoir to the infusion port, atelemetry module 720 for providing bi-directional communication betweenthe implantable device 105 and the external device 110, a memory 725 forstoring the various software modules for use with the present invention,a therapy monitor module 735, and (optionally) a therapy managementmodule 115. The therapy monitor module 735 provides one or moreperformance parameters related to therapy management including, but notlimited to, drug flow rate, drug quantity in reservoir, drug type, drugusage history, etc. Drug usage monitored by the therapy monitor module735 may include, for example and without limitation, the quantity drugconsumed by the patient, the rate in which the drug is being consumed bythe patient, and the estimated date that the drug in the pump will beexhausted based on the previous two parameters. Drug usage maybedetermined, for example, by way of a pump reservoir sensor 750 thatsenses the amount of drug remaining in the pump reservoir. For example,the pump reservoir sensor 750 disclosed in U.S. Pat. No. ______, havingapplication Ser. No. 09/070,255, filed Apr. 30, 1998, and entitled“Reservoir Volume Sensor”, may be used.

[0050] The external device 110 generally includes a telemetry module 705and a memory 710 for storing various software applications and modulesfor use with the present invention. Stored within the external device110 is the therapy management module 115. The therapy management module115 gathers data regarding the implantable device 105 to make decisionsregarding the management of medical therapy. Such decisions include, butare not limited to, reprogramming of the implanted device 105, warningsassociated with the therapy to the patient/caregiver/physician, changeddrug formulations, etc. The patient/caregiver/physician areautomatically notified of any such changes. Provisions in the systemallows for confirming or other responses to insure adequatecommunication and commitment for action. All data and fiducial markers(e.g., date, requester) are sent to database 120 for archive andpotential later retrieval.

[0051] Database 120 includes a human clinical records database oftherapy performance related to various indications and various drug usedto treat those indications. This database 120 is likely generated fromvarious sources, including previous pump patient experience, and isconstantly updated and managed. This database is preferably accessibleby the therapy management module 115.

[0052] The pump telemetry data is obtained by or through the externaldevice 110 that is held in reasonable proximity with the pump 105implanted within patient. The external device 110 interrogates theimplanted pump 105 and information is uplinked from the pump 105 to theexternal device 110. In addition, data from the pump is provided to thetherapy management algorithm 830 (discussed herein).

[0053] As shown in the block diagram of FIG. 10, the data regarding theimplantable device 105 that the therapy management module 115 uses tomake its determination include, for example, pump performanceinformation from the therapy monitor module 735, pump manufacturerrequirements 820, physician requirements 815, and patient requirements825. The pump manufacturer requirements 820 preferably provides acontinuous real time input to the therapy management module 115 to allowthe pump manufacturer to specify limits for changing therapy parametersto conform with the design of the implanted device 105. The physicianand patient requirements 815 and 825 include requirements of the drugtherapy that are selectable and generally specific to the patient and/orphysician therapy preferences (e.g., flow rate). These requirements 815and 825 are determined by the physician who may input these requirementsvia a general-purpose computing device. The therapy management algorithm830 receives the requirement information 815-825 either by manual entryof the information or could be downloaded via the Internet, a localnetwork, or a telephone line. For archival purposes, all data is storedin database 120.

[0054] Still referring to FIG. 10, the therapy management module 115includes a therapy management algorithm 830 that serves to determine themanagement of the medical therapy provided to the patient.

[0055]FIG. 11 is a flow chart illustrating the procedure followed by thetherapy management module 115. As discussed above, the therapymanagement module 115 utilizes a therapy management algorithm 830 tomake this determination. At step 905, the therapy management algorithm830 determines whether a therapy change is needed. The therapymanagement module 115 may make this determination either continuously,periodically (e.g., on a daily basis), or even manually (e.g., manuallyinterrogating the implantable device 105 for it's drug status and druginfusion rate conditions). If a therapy change is not required, a recordthat this determination was made is stored in the database 120 (at step920). On the other hand, if the therapy management algorithm 830determines that a therapy change is required, at step 910, the therapymanagement module 825 performs a reprogramming of the pump 105. At step920, event data (such as the therapy change) are stored in the database120. Finally, at step 925, whether or not the therapy is changed, thetherapy management algorithm 830 requests payment for the therapymanagement service.

[0056] For example, in one embodiment, the sensor data from sensor 750could be body vibration or activity information when the body vibrationis due to tremor in an extremity. The therapy management algorithm 830compares this sensor output or level of tremor to the physicianrequirements 815 which may be a low level of tremor and if the tremorlevel is too great, either in frequency or amplitude or somecombination, the therapy management algorithm 830 could decide that atherapy change is needed. This information is transmitted to database120 and the pump 105 is reprogrammed to infuse a larger amount of theantitremor agent. Alternatively, if the tremor level is not so great soas to require a therapy change, then this information is communicated tothe database 120 and the pump 105 is not reprogrammed to infuseadditional drug. Thus, in this example, a main decision the therapymanagement algorithm 830 makes is to compare the physician requirements815 for the level of tremor to what they pump 105 actually senses is thetremor level. A decision is then made by the therapy managementalgorithm 830 as to whether to reprogram the pump for additional druginfusion.

[0057] When the event is added to the database 120, the therapymanagement algorithm 830 decides whether a payment request for thistherapy management procedure should be made or whether payment requestshould be made, depending on whether the pump 105 is reprogrammed.

[0058] In another embodiment, the physician requirements 815 could bereplaced with clinical data guidelines information. The therapymanagement algorithm 830 and all other elements of the flow chart wouldbe the same with the exception that the therapy management algorithm 830would use the clinical data guidelines to determine whether or not thepump should be reprogrammed. Alternatively, the physician requirements815 could be used in a secondary level with the clinical data guidelinesas a primary reference for the therapy management algorithm 830.

[0059] When the therapy management algorithm 830 makes a decision forpump programming, it is accomplished using the external device 110 beingplaced in reasonable proximity to the pump 105 in the patient.

[0060] It will be appreciated that the present invention may beimplemented using other embodiments. Those skilled in the art recognizethat the preferred embodiments may be altered and modified withoutdeparting from the true spirit and scope of the invention as defined inthe appended claims.

I claim:
 1. A computing device in communication with an implantabledevice for delivering therapy a patient, the device having a a therapymonitor module configured to monitor at least one performance parameter,the computing device comprising in combination: (a) a therapy managementmodule for determining management of medical therapy based upon theperformance parameter from the therapy monitor module; (b) a memory forstoring therein the therapy management module and at least onerequirement parameter; and (c) a telemetry module providingbi-directional communication between the computing device and theimplantable device.
 2. The computing device of claim 1, wherein therequirement parameter stored in the memory is selected from the groupconsisting of device manufacturer requirements, patient requirements,and physician requirements.
 3. The computing device of claim 1, whereinthe therapy management module includes a therapy management algorithm tomanage the therapy to the patient.
 4. The computing device of claim 1,wherein the therapy management module is capable of contacting at leastone entity, wherein the entity is selected from the group consisting ofa pharmacy, a caregiver, a physician, a hospital, and the patient. 5.The computing device of claim 1, wherein the computing device isoperatively coupled to the entity via a computing network.
 6. Thecomputing device of claim 5, wherein the computing network is anInternet.
 7. A system for providing treatment therapy to a patientcomprising in combination: (a) an implantable device comprising: i) ahousing; ii) electronics contained in the housing for adjusting thetherapy provided by the implantable device; iii) a telemetry modulecoupled to the electronics for providing bi-directional communicationbetween the delivery device and an external programmer; iv) a firstmemory coupled to the electronics; and v) a therapy monitor modulecoupled to the electronics, the therapy monitor configured to monitor atleast one performance parameter; and (b) an external programmercomprising i) a second memory for storing at least one requirementsparameter; ii) a telemetry module providing bi-directional communicationbetween the external programmer and the implantable device; and iii) atherapy management module stored in the second memory for determiningmanagement of the medical therapy provided by the implantable device. 8.The system of claim 7, further comprising: (c) at least one entityselected from the group consisting of an insurance provider, a pharmacy,a hospital, a caregiver, a physician, and a device manufacturer; and (d)a computing network coupling the external programmer to the entity. 9.An implantable drug delivery device having a performance data reportingfeature, comprising: (a) a housing; (b) a drug reservoir carried in thehousing configured to contain a therapeutic substance; (c) a flowcontrol coupled to the drug reservoir for controlling the flow of thetherapeutic substance from the drug reservoir through an infusion port;(d) electronics coupled to the flow control and a power source; (e) atelemetry module coupled to the electronics; (f) memory coupled to theelectronics, the memory containing pump performance acquisitioninstructions; (g) at least one monitoring module coupled to the memoryand the electronics that monitors at least one pump operation variableaccording to the pump performance acquisition instructions to produceperformance data; and (h) at least one reporting module coupled to thememory and the electronic, the reporting module configured to activatethe telemetry module to report performance data.
 10. The implantabledrug delivery device of claim 9, wherein the monitoring modulecommunicates via telemetry with therapy management module.
 11. A methodfor reporting performance data of an implantable drug delivery device,comprising: (a) establishing patient parameters; (b) establishing a basetherapy; (c) performing the base therapy; (d) acquiring patient datarelated to the base therapy; (e) calculating at least one relationshipamong the patient parameters, base therapy, and patient data; (f)deciding whether a therapy issue should be reported; and (g) reportingthe therapy issue from the implantable drug delivery device into acommunications medium.
 12. Computer executable instructions forperforming the steps recited in claim
 11. 13. The method of claim 1,wherein the step of deciding whether a therapy issue should be reportedis performed by a therapy management algorithm.
 14. The method of claim11, wherein the step of reporting the therapy issue includes the step ofcontacting a party selected from the group consisting of a pharmacy, acaregiver, a physician, a hospital, and the patient.
 15. The method ofclaim 14, wherein the step of contacting is performed via a computingnetwork.
 16. The method of claim 14, wherein the step of contacting isperformed via an Internet.